US FDA releases draft guidance on expedited review for breakthrough devices – and they want access to your wordprocessor and to chat a lot by phone! We take a look at how FDA wants to roll up its sleeves and work with device developers.
On 25 October, the US FDA released final guidances on when a changes to hardware or software require a new 510(k). The new guidances provide a wealth of detail and lots of flow charts. Underneath it all there’s strong reliance on formal ISO 14971 risk assessment – which should mean much greater consistency in need to file new 510(k) and need for Conformity Assessment review in Europe and other GHTF model markets.
Last week the US FDA announced a new web page setting out its current Small Business Program. This program provides fee breaks for small businesses seeking FDA regulatory approvals. The fee breaks are substantial (up to 75% off) and a business doesn’t have to be all that small to qualify. Non US businesses can apply too.
Businesses wishing to market Class II Medical devices (or certain Class I and III) or IVDs in the USA are required to obtain premarket clearance through the 510(k) notification process.
When you’re considering the US market for your product, you may have spent hours browsing through the internet, reading through mountains of regulations, guidance documents and standards, researched published white papers and yet… you’ve not been able to answer one fundamental question, “Do you have the right 510(k) strategy?”
Innovative Pathways for fast track approval of new technologies are continually in the news. These pathways attempt to serve industry development goals in the guise of meeting unmet clinical needs. Still it’s a laudable goal. But are these programmes effective? or safe?
US FDA this week backed away from proposals to directly regulate Lab Developed Tests, signalling an increased caution ahead of the new administration. But FDA has also said it intends to bring forward further proposals soon – and what does this mean for manufacturers seeking to market tests through LDT?